Human Interface and Device for Ultrasound Guided Treatment

ABSTRACT

A system and method for providing real-time, image-guided high intensity focused ultrasound (HIFU) targeting and treatment of tissue. In one embodiment, the system includes an HIFU applicator and a user interface with a touchscreen display for three-dimensional visualization of the tissue. Image frames displayed on the user interface depict real-time images of the tissue, including an image parallel to a feature of the applicator and an image orthogonal to the parallel image. Reference lines may be sketched using the touchscreen and displayed on the image frames. In one embodiment, tissue boundaries are detected and marked on the image frames, either by the user or automatically by the system. In another embodiment, the user interface includes a footswitch for the user to interact with the system. In another embodiment, the system includes an ultrasound imaging component configured to undock from the system for use as a stand-alone ultrasound imaging device.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 61/672,213, filed Jul. 16, 2012, and U.S. ProvisionalPatent Application No. 61/798,831, filed Mar. 15, 2013, the disclosuresof which are incorporated by reference herein in their entirety.

BACKGROUND

The use of focused ultrasound for treating tissues is a relatively newfield. Devices providing ultrasound therapy are being developed and newways are being found for users to interact with such devices.

There is increasing interest in devices that provide image-guidedfocused ultrasound therapy. With an image-guided ultrasound device, thegeneral principle is to provide the user sufficient information so theycan safely and effectively target and treat tissues. Various devicesdescribed herein for illustrative purposes use ultrasound imaging forvisualization and high-intensity focused ultrasound for treatment.

SUMMARY

The following summary is provided to introduce a selection of conceptsin a simplified form that are further described below in the DetailedDescription. This summary is not intended to identify key features ofthe claimed subject matter, nor is it intended to be used as an aid indetermining the scope of the claimed subject matter.

This disclosure describes unique ways in which a user may interact withan ultrasound device. It also describes ways in which the device mayautomatically respond or behave as an alternative to the userinteraction.

High intensity focused ultrasound (HIFU) systems described hereinprovide real-time, image-guided HIFU treatment of tissue. In at leastone embodiment, a system includes a HIFU applicator configured todeliver HIFU energy to the tissue, a HIFU generator configured tocontrol and transmit the HIFU energy to the HIFU applicator, anultrasound imaging device configured to control imaging of the tissue,and a user interface including a display, which may be a touchscreendisplay. The user interface is configured to display images of thetissue on the display for three-dimensional visualization of the tissue,wherein the images include an active parallel frame depicting areal-time image plane parallel to a feature of the applicator and anactive orthogonal frame depicting a real-time image plane orthogonal tothe active parallel plane.

The user interface may be further configured to display reference framesin addition to the active parallel frame and the active orthogonalframe, wherein the reference frames include a reference parallel frameand a reference orthogonal frame. In at least one embodiment, thereference parallel frame provides a static view of the active parallelframe and the reference orthogonal frame provides a static view of theactive orthogonal frame.

The user interface may be further configured to display reference linesadded to the reference parallel frame and the reference orthogonalframe, and duplicate the reference lines on the active parallel frameand the active orthogonal frame. The user interface may include devicecontrols, which may be one or more control icons accessible via thedisplay, for controlling the ultrasound imaging device. In at least oneembodiment, the system is configured to automatically set and adjust oneor more of the device controls.

The system may be further configured to detect and mark tissueboundaries, calculate and adjust treatment parameters based on thedetected tissue boundaries, and display the marked tissue boundaries onthe display. The user interface may be configured to display a 360degree sweep view of the tissue volume. The ultrasound imaging devicemay be connected to the system via a docking interface.

Methods of interacting with a high intensity focused ultrasound (HIFU)system during real-time, image-guided HIFU treatment of tissue are alsodescribed herein. In at least one embodiment, a method includesdelivering HIFU energy to provide treatment to the tissue, anddisplaying ultrasound images of the tissue on a user interface duringtreatment. The images include an active parallel frame depicting areal-time image plane parallel to a feature of the applicator and anactive orthogonal frame depicting a real-time image plane orthogonal tothe active parallel plane.

The method may further include displaying reference frames in additionto the active parallel frame and the active orthogonal frame duringtreatment, wherein the reference frames include a reference parallelframe and a reference orthogonal frame. In at least one embodiment, thereference parallel frame provides a static view of the active parallelframe and the reference orthogonal frame provides a static view of theactive orthogonal frame.

The method may further include adding reference lines to the referenceparallel frame and the reference orthogonal frame, and duplicating thereference lines on the active parallel and active orthogonal frames.

The method may further include controlling an ultrasound imaging devicethrough device controls, which may be one or more control iconsaccessible on a display. In at least one embodiment, the method includesautomatically setting and adjusting one or more of the device controls.

The method may further include detecting, marking, and displaying tissueboundaries, as well as calculating and adjusting treatment parametersbased on the detected tissue boundaries. In at least one embodiment, themethod includes automatically detecting, marking, and displaying tissueboundaries, and automatically calculating and adjusting treatmentparameters based on the detected tissue boundaries. The method mayfurther include displaying a 360 degree sweep view of the tissue volume.

DESCRIPTION OF THE DRAWINGS

The foregoing aspects and many of the attendant advantages of thisdisclosure will become more readily appreciated as the same becomebetter understood by reference to the following detailed description,when taken in conjunction with the accompanying drawings, wherein:

FIG. 1 illustrates a therapeutic ultrasound device in accordance with atleast one embodiment;

FIG. 2 illustrates a user interface layout including an initial screenwith two orthogonal image planes depicted in accordance with at leastone embodiment;

FIG. 3 illustrates a user interface layout including a screen with agraphical overlay of the embodiment illustrated in FIG. 2;

FIG. 4 illustrates a user interface layout including a screen with alayout with a full volume mode;

FIG. 5 illustrates a user interface layout including a screen with ascanplane position manual control;

FIG. 6 illustrates a user interface layout including a pretreatmentscreen showing reference and active images;

FIG. 7 illustrates a user interface layout including a screen with usercontrols in a targeting mode;

FIG. 8 illustrates a user interface layout including a screen displayingsketched reference lines;

FIG. 9 illustrates a user interface layout including a screen with anultrasound imager control panel;

FIG. 10 illustrates a user interface layout including a pretreatmentscreen with a footswitch control;

FIG. 11 illustrates a therapeutic ultrasound device in accordance withat least one embodiment;

FIG. 12 illustrates a user interface layout including a screen layoutwith two active image planes and two reference planes;

FIG. 13 illustrates a user interface layout including a screen layoutwith two image planes;

FIG. 14 illustrates a user interface layout including a screen layoutwith an alternative quad-view with critical controls section identified;and

FIG. 15 illustrates a user interface layout including reference imagesoverlaid on the screen.

DETAILED DESCRIPTION

This section describes various embodiments of therapeutic ultrasounddevices that include user interfaces in accordance with the presentdisclosure.

The primary components of at least one embodiment of a device describedherein (see FIG. 1) are listed in Table 1.

TABLE 1 Device primary components Number Description 10 HIFU device 12Ultrasound imaging component (preferably, commercial grade) 14 HIFUgenerator that controls and outputs the power waveform to the HIFUtransducer 30 User interface that includes a video/image display withtouchscreen for input, and a footswitch 16 Computer for interfacing theprimary device components 18 Connector and associated cabling tointerconnect the HIFU generator and imaging components to the HIFUapplicator 20 HIFU applicator that houses the HIFU transducer, imagingtransducer, high bandwidth ultrasound receiver, and motors/mechanismsfor steering the HIFU energy

In at least one embodiment, an image-guided focused ultrasound device 10includes a user interface 30 that gives a user the ability to visualizepatient tissues in real time both while targeting and treating thetissues. In at least one embodiment, the user interface 30 provides theuser with images for visualizing three-dimensional tissue volumes. Theuser is provided with two real-time orthogonal views 42, 44 (e.g., x-zand y-z planes, or from the user's perspective in this particularembodiment, transverse and sagittal planes), preferably simultaneously,to allow basic three-dimensional visualization of the patient's tissueand tracking of ultrasound therapy applied to the tissue (see FIG. 2).An active parallel frame 42 provides the real-time view of the sagittalimage. When appropriately positioning the applicator, the parallel planepasses through the long axis of the applicator and is parallel to a linepassing through a feature of the applicator, such as both handles (thisplane is typically parallel to the user). An active orthogonal frame 44provides the real-time view of the transverse plane, which is orthogonalto the active parallel frame 42, as shown in FIG. 2.

The user interface 30, as described herein, may include a variety oficons that allow the user to select certain functionality and otherwiseinteract with the ultrasound device 10. In the embodiment shown in FIG.2, for example, an icon 40 is shown in the upper left corner of eachimage 42, 44 to indicate the orientation (position) of the respectiveimage plane within the patient's tissue. To correlate the image plane tothe patient, a corresponding indication on the ultrasound applicator 20may be provided in the form of a color, shape, or other markings orfeatures. The implementation described herein is intuitive. For anapplicator 20 with two handles spaced at 180 degrees apart, one imagealigns with the user's hands (handles), and the other image alignsorthogonal to a plane through the user's hands. The correspondingapplicator motion is also intuitive as well, since a left motion alongthe plane through the handles may result in the tissue “sliding” throughthe ultrasound image (as if one were looking though a scope or viewfinder). The orthogonal plane can be programmable or selectable as towhether pushing the applicator 20 away results in a “left slide” or a“right slide” of the applicator 20 over the tissue. In addition, thereis a provision for displaying a graphic of the applicator 20 moving overthe patient on the screen of the user interface 30. The device 10 mayuse accelerometer data from the applicator 20 (or other inputinformation, such as image data) to determine the motion of theapplicator 20 and reflect that motion on the screen of the userinterface 30. The orientation of the patient relative to the applicator20 is settable by the user (e.g., head to the left or right). This modewould primarily be available in a training mode, but could be availableduring treatment. This data would also be available for motion detectionduring treatment, could be used independently or combined with processedultrasound image data to detect motion, and may inform or alarm the userduring treatment (e.g., regarding a shift during treatment).

With regard to identifying target tissue, a graphical overlay 50 on thescreen of the user interface 30 may be used to show the target volume52, a safety margin 54, and pre focal and post focal field lines 56, 58(see FIG. 3). The target volume 52 indicates the tissue to be treated.The safety margin lines 54 indicate the distance away from the targetvolume 52 to keep critical tissue away such as the serosa, bowel, etc.The pre focal and post focal lines 56, 58 indicate the boundaries of theoverall HIFU field for the entire treatment (e.g., as the focus is movedabout). The overlay 50 can be turned off or disabled with overlay on/officon 92 for unobstructed viewing, then re-enabled when desired, e.g.,for treatment (see FIG. 7).

In addition, the device 10 may provide the user with a full-volumescanning mode (see icon 100 of FIG. 7), where the scanplane is rotatedabout a vertical axis, e.g., a full 180 degrees, to allow the user tovisualize some portion or an entire volume of tissue. The relative angleof rotation is either automated or manually positioned via the userinterface 30 (see FIG. 4).

The scanplane position (angle) of the ultrasound image, specificallyrelative to the applicator and indirectly relative to the patient, maybe indicated to the user via the same icon 40 used to reference theorientation of the aforementioned orthogonal scanplanes (see FIG. 4). Inaddition, the user may pause the automatic sweeping of the scanplaneposition and manually position the scanplane using controls 60, 62, 64,for example, as shown in FIG. 5.

In at least one embodiment, the user can rotate the image plane ineither a clockwise or counterclockwise direction by momentarily,repeatedly, or continuously selecting the respective step icons 62, 63.To restart the automated sweeping, the user selects the Sweep/Pause icon64.

Upon exiting the targeting mode, the user is provided two targetingimage frames. Reference parallel frame 46 and reference orthogonal frame48 are maintained for reference (left), and two additional image frames(right) become active, namely active parallel frame 42 and activeorthogonal frame 44 (see FIG. 6). In the active parallel and orthogonalframes 42, 44, the tissue can be observed in real time, while in thereference parallel and orthogonal frames 46, 48, the image of the tissueis captured at one point in time, for example.

The right-side active image planes (active parallel frame 42 and activeorthogonal frame 44) are used for real-time tracking of tissue treatmentthroughout the treatment session, with the reference image planes(reference parallel frame 46 and reference orthogonal frame 48)remaining constant on the left side. Also shown on the screen of theuser interface 30 is an icon 70 used for selecting between various imagefilters. These image filters include, but are not limited to, filtersthat remove image reverb artifacts using various techniques and/or edge,boundary, or tissue-enhancing filters. In the illustrated embodiment,most controls are available in both the targeting and pretreatment modes(see FIG. 7).

The user can modify treatment parameters, initiate treatment, orexit/power off. The characteristics of these controls and otherinteractions or features of the device 10 will be discussed below.

The device 10 may incorporate multiple features that assist the user intracking the patient's tissue during treatment. First, the referenceplanes (reference parallel frame 46 and reference orthogonal frame 48)on the left side of the screen of the user interface 30, which show thetargeted tissue, stay consistent throughout treatment (FIG. 6). Theintent is to keep the applicator 20 positioned such that the activeimages (active parallel frame 42 and active orthogonal frame 44) on theright side of the screen of the user interface 30 consistently appearlike the reference images. The reference planes are used to ensure thatthe position of the applicator 20 relative to the patient remainsconsistent during treatment. In addition, in cases where the user movesthe applicator 20 in an unintended direction, the patient moves, or theapplicator 20 is otherwise not on target, the user can pause thetreatment, reposition the applicator 20 such that the active images arealigned similar to the reference images, and then restart treatment.

Second, the user has tools 80, 82, 84 for drawing or sketching referencelines 110 on the reference plane images (see FIGS. 7 and 8). Thesereference lines 110 are typically used to mark tissue boundaries. Thereference lines 110 can be drawn with finger, stylus, mouse, trackball,touchpad, or other suitable device on the touchscreen display of theuser interface 30. These reference lines 110 are thereafter duplicated112 on the active plane images, which assist the user in keeping theapplicator 20 on target (FIG. 8). In addition to the drawing tool 80,there is an eraser tool 82 for erasing part or all of a reference line,and an erase function 84 for erasing all reference lines. The erasertool data may be input via finger, stylus, and/or other tools similar tothe line-drawing tool. As with the overlay 50, the lines 110, 112 can bevisible or hidden for unobstructed viewing of the ultrasound image.

Reference lines 110 could also be generated automatically using commonsignal and image-processing techniques that can detect dominantfeatures, such as boundaries or edges, in the reference images. Uponactivation by the user (or automatically), the device 10 may present theuser with proposed reference lines based on detected features, fromwhich the user can choose to accept all, some, or none as referencelines on the screen of the user interface 30. In addition, an embodimentof the device 10 may enhance the tissue boundaries (edges) usingcurrently known signal and image-processing techniques (e.g., enhancingsteep gradients across the image data).

The device 10 may incorporate an ultrasound imaging system forvisualizing the patient's tissues. The ultrasound imaging system may bea commercially available system. As described herein, controls for acommercial ultrasound system may be included in the user interface 30 ofthe HIFU device 10 (see FIG. 9) by activating icon 96 (see FIG. 7).

In the illustrated embodiment, the ultrasound imaging controls presentedto the user include Time Gain Control (TGC) 120, enabling or disablingharmonic imaging 122, and adjusting the overall gain 124. In otherembodiments, the user interface 30 may be further enhanced withadditional or different imaging ultrasound controls that are presentedto the user. In addition to the user controls, there are controls thatmay be automatically adjusted by the device 10, such as overall gain andTGC presets, and automatic gain change as depth is varied.

In at least one embodiment, the distance between the imaging transducerand the patient interface varies as a function of the HIFU treatmentdepth, since the imaging transducer is moved along with the HIFUtransducer within a transducer fluid volume. The transducer fluid pathincreases and the tissue path decreases as the depth of treatmentdecreases. In this embodiment, the device 10 reduces overall gain of theultrasound imaging system to account for the reduced tissue path betweenthe transducer and the target volume. For some imaging systems, thedevice 10 can also adjust the output power as the transducer fluid pathlength is varied.

In addition, the device 10 may provide the user with options foredge-enhancing filters (e.g., enhancing steep gradients in the image),reverb and motion filtering (via Doppler and/or minimum filtering),elastography methods to enhance differences in tissue stiffness, andother ultrasound imaging enhancements that assist the user withdifferentiating between tissue types (e.g., clearer identification offibroid boundaries).

The device 10 may include multiple features by which the user can set oradjust the treatment regimen for affecting treatment parameters. Forexample, in at least one embodiment, the user first operates the device10 to choose a target volume. The device 10 may provide an icon on theuser interface 30 that, when selected, brings up a menu of treatmentvolume options (using, for example, a scrolling, mouse, or touch screenselection). Alternatively, the target volume shown on the screen of theuser interface 30 could change size or shape each time the user selectsthe icon 94 on the screen of the user interface 30 (see FIG. 7). Theicon 94 could also change (e.g., by way of text or graphic) with eachtarget volume selection, providing feedback to the user. Alternatively,in other embodiments, the device 10 iteration(s) may allow the user tochange the size of the volume simply by touching or clicking on thetarget volume boundary on the user interface 30 and dragging theboundary to the desired target volume size and/or shape.

Every target volume may have associated with it a unique set oftreatment parameters, such as peak acoustic power, duty cycle, andmotion pattern. In at least one embodiment, an overall target volume ismade up of multiple unit volumes and the treatment parameter(s) set foreach unit volume is/are dependent on where the unit is located relativeto the other unit volume(s). In an embodiment, the device 10 isimplemented using predetermined treatment volumes (e.g., sphericalshapes), though other embodiments may include an interface that allowsthe user to sketch arbitrary shapes on the orthogonal planes (or morethan two planes), if desired. In such embodiments, the device 10 isconfigured to interpolate between the sketched lines and create a volumebased on the sketched boundaries. The created target volume is displayedfor the user to modify or accept. The device 10 then uses one or morealgorithms to determine the appropriate treatment parameters fortreating the target volume as displayed.

Second, the treatment regimen may be affected by the depth of treatment,due to the attenuation of the ultrasound as it passes through thetissue. In at least one embodiment of the device 10, the user chooses atarget depth for the tissue volume via arrows 98 on the screen of theuser interface 30 (see FIG. 7). The arrows 98 could be replaced withsimilar functions such as a slide bar or entered numeric value. Furtherdevice 10 enhancements may include the ability to touch or click on thetarget volume and drag the volume to a new target depth on thetouchscreen of the user interface 30.

Third, the treatment regimen may be dependent on the presence of otherphysiological aspects of the patient, such as bladder fluid, in theacoustic path. In at least one embodiment, the device 10 providescursors on the screen of the user interface 30 to mark upper and lowerboundaries of the bladder. In cases where bladder fluid is in theacoustic path, the user may select one or more icons 90 on the screen ofthe user interface 30 to make the cursors visible and then mark thebladder upper and lower boundaries. The user may adjust the cursorpositions by dragging them via the touch screen of the user interface30, though one could use a stylus, mouse, arrow keys, entered value, orother means to adjust the positions.

In one embodiment, the user is presented with simple line cursors. Inother embodiments, the user interface 30 is enhanced to include curvedor arbitrary lines for more complex and more precise calculation of thetreatment parameters. In addition, embodiments of the ultrasound device10 may automatically detect the boundaries of the bladder using knownboundary detection algorithms on the image data, and use subsequentcalculations to determine the treatment parameters based on the detectedboundaries, thus eliminating the need for the user to interact with thisparameter.

Fourth, the treatment parameters may be influenced by the thickness ofthe patient's abdominal wall. Similar to the bladder, in at least oneembodiment, the user can enable a cursor on the screen of the userinterface 30 and use the cursor to identify the abdominal wall depth aswell as adjust the position of the cursor to mark the lower wallboundary. Methods of adjusting the cursor utilize icon 88 and aresimilar to the aforementioned methods for adjusting the bladder wallcursors (see FIG. 7). In addition, similar to the bladder walldetection, embodiments of the device 10 may use currently known (orfuture developed) methods to automatically determine the abdominal wallboundary and subsequently calculate and adjust the treatment parameters.In both cases, the automatically determined boundaries could bepresented to the user (e.g., via the screen of the user interface 30)for verification and/or modification.

Fifth, in embodiments of the ultrasound device 10 where the patientinterface cap is flexible and the transducer fluid path length betweenthe transducer and the patient tissue is dependent on the volume oftransducer fluid in the system, the device 10 may be configured toaccount for the fluid standoff in the process of calculating the outputpower of the ultrasound signals. The position of the patient interfacerelative to the transducer may be adjusted by the user (e.g., using thescreen of the user interface 30) or may be automatically determined bythe device 10. In the embodiment illustrated above, the “skinlinemarker” icon 86 (see FIG. 7) activates a blue line marker (cursor) onthe image that is used to mark the surface of the patient's tissue(skin). This manual feature is implemented and used in at least oneembodiment of the device 10, though the feature may be automated inother embodiments of the device 10. In an automated embodiment, thedevice 10 processes the image data to identify the boundary of thepatient's tissue by looking for the transition from the foreground darkor low amplitude reflection data to the first bright or high amplitudereflection data. Other processing techniques may be used to detect thistransition, such as processing raw RF data for the first significantreflection. This first transition is the patient's skin, which is thenused for calculating the standoff distance.

When in pretreatment mode, the user is presented with the option ofenabling the footswitch (see FIG. 10), in at least one embodiment. Uponactivation of the footswitch, the Activate Footswitch icon 130 may beconfigured to change to an Activate Treatment icon, and the device 10programs the HIFU parameters and positions the transducer to starttreatment. The device 10 is in Treatment Mode while the footswitch isenabled and the device 10 is either ready to treat or activelyoutputting HIFU signals.

When the user presses the footswitch, the icon changes from the ActivateTreatment icon to a Stop/Pause Treatment icon, and the device 10implements a regimen to treat the targeted treatment volume. The device10 disables the footswitch and notifies the user when treatment iscomplete, at which time the icon changes back to indicate a pretreatmentstate. If the user releases the footswitch before the device 10completes treatment, the icon may be configured to change to an inactiveTreatment Paused icon, and the device 10 enters a Treatment Pausedstate.

In the Treatment Paused state, the device 10 may be configured todisplay options to the user. The user may choose to cancel the treatmentand return to the pretreatment state, or simply re-press the footswitchto continue treating the target volume using the previously determinedtreatment regimen. While in the Treatment Paused state, the user mayalso choose to enter an imaging state and conduct a full volume sweep ofthe target volume to verify the conditions of the target volume andacoustic path, return to the Treatment Paused state, and then choose tocancel or return to providing treatment to the patient's tissue.

While outputting therapeutic ultrasound signals, the device 10 mayinclude multiple indicators to the user that treatment is active. Thedevice 10 may emit a sound, show an icon on the screen of the userinterface 30 (e.g., the treatment icon changes to a stop treatment icon,and/or other indications), and/or illuminate the applicator 20 whileoutputting treatment. In addition, there may be a treatment timer on thescreen of the user interface 30 indicating progress of the treatmentregimen to the user. This treatment progress indicator could also beimplemented with a progress bar, shading the target volume, or otherrelevant means of indication.

Although the embodiments of the device 10 discussed above areimplemented with a footswitch, other embodiments of the device 10 couldincorporate one or more control switches on the applicator 20, voicecommands, proximity sensors, combinations of the aforementioned, orother means for the user to activate the output of HIFU signals.

While outputting treatment, an uncoupled applicator 20 (relative to thepatient) would not harm the patient, though it would not result ineffective treatment and such conditions could potentially harm theapplicator 20. In at least one embodiment, the device 10 monitors theHIFU signal reflected from the patient interface and compares it to apredetermined threshold. If the reflected signal is greater than thethreshold, the device 10 assumes the applicator 20 is not fully coupledto the patient and notifies the user. A value lower than the thresholdwould indicate the device 10 is coupled to the patient. In otherembodiments, the thresholds and comparisons may be configureddifferently such that a value lower than the threshold indicates theapplicator 20 is not fully coupled, and a value higher than thethreshold indicates the device 10 is coupled to the patient. Inaddition, the device 10 may be configured to monitor the HIFU signal(s)reflected from tissues deeper than skinline (e.g., near focus) andcompares these with expected values. This data may be combined withother data to enhance the coupling detection algorithm.

While in some embodiments, the device 10 allows the entry of patientdata (e.g., name, etc.) and stores device data during treatment (foranalysis, etc.), other embodiments of the device 10 may not provide theuser with an option to enter patient data and device 10 does not storedata during treatment. Further embodiments of the device 10 may allowthe user to input patient data, treatment planning information frompast, current, or future treatments, or other related data. In addition,the device 10 could also store treatment data (values, video, andimages) from a given treatment session or sessions for later use by theuser or others.

Preferably, the device 10 incorporates multiple features that enhancethe safety of the device 10. First, embodiments of the device 10 maydetect and inform the user in case of insufficient coupling, asdiscussed above. The energy reflected off the patient interface from theHIFU waveform is monitored, and if it is too high (or too low) of avalue, the device 10 may determine that the device 10 is not properlycoupled, cease outputting treatment, and inform the user to check thepatient coupling.

Further embodiments of the device 10 may include monitoring the tissueboundaries in the active image(s) and comparing them to the position ofthe tissue boundaries in the reference image(s). If the boundaries arenot found to be within a predetermined value (threshold), a warning maybe displayed or communicated to the user to check the alignment of theapplicator relative to the patient. The user could pause treatment,realign the applicator 20 over the target tissue, or choose to ignorethe warning. If the boundaries are not found to be within a secondpredetermined threshold (value), the device 10 may automatically pausetreatment and an error may be displayed or communicated to the userindicating the treatment is paused and to check the alignment. The userwould then reposition the applicator 20, clear the error, and reinitiatetreatment, thereby continuing to treat the target volume. As a secondarymeans of ensuring an aligned applicator 20 is on target (where theprimary means is the user monitoring the ultrasound images), the usermay have the option to set the two thresholds and enable or disable thefeature. Additional configurations include an accelerometer that can beused independently or combined with the image data to determine motionof the applicator 20 and accordingly inform the user.

The device 10 includes the ability to use independent ultrasound imagingfor general ultrasound imaging. For example, there are twoimplementations of this feature described below. Table 2 below setsforth various ultrasound imaging components shown in the accompanyingfigures and described herein.

TABLE 2 General ultrasound imaging components Number Description 10Therapeutic ultrasound device 12 Imaging ultrasound component 22Connection between the imaging ultrasound component and the rest of thetherapeutic ultrasound device 26 Hand-held ultrasound imaging probe 24Connector between the ultrasound imaging probe and the therapeuticultrasound device

In at least one configuration of integrated diagnostic imagingultrasound, the HIFU device 10 incorporates one or more connection(s) 24for hand-held ultrasound imaging transducer(s) 26 (see FIG. 11). TheHIFU device 10 is then used as a diagnostic ultrasound imaging system.

In a dockable portable ultrasound configuration, the ultrasound imagingcomponent 12 is disconnected via a docking interface 22 by the user fromthe HIFU device 10. The ultrasound imaging component 12 is thenconnected via connector 26 directly to the imaging transducer 24 andused as a stand-alone diagnostic ultrasound imaging system.

Alternative user interface layouts include multiple screen layouts foralternative user interaction with the device 10. In one embodiment, thescreen of the user interface 30 has two active image planes and tworeference image planes (see FIG. 12).

In this embodiment, the right-side screens display two orthogonal images(active parallel frame 42 and active orthogonal frame 44) and are alwaysactive (imaging). The left-side screens (reference parallel frame 46 andreference orthogonal frame 48) are blank on first entry to the userinterface, and are populated with images from the right side when theuser chooses (e.g., selects capture image) or when the user selects tostart treating (e.g., activates the footswitch). The feature ofcapturing the images may be selected via a variety of modes, including,but not limited to, a footswitch, switch/sensor on the applicator 20,voice command, or through a touchscreen of the user interface 30. If theuser has preselected captured images prior to activating the footswitch,the user may be prompted to choose whether the previously capturedimages are to be replaced. Once the device 10 is in treatment mode, thereference images (reference parallel frame 46 and reference orthogonalframe 48) are static and do not change. In other embodiments and/or useconditions, the static images, namely reference parallel frame 46 andreference orthogonal frame 48, may be replaced while in treatment mode.

In another embodiment, the screen of the user interface 30 has only twoactive image planes that are visible, namely active parallel frame 42and active orthogonal frame 44 (see FIG. 13), and the image planes havea larger format than that with four image planes (see FIG. 12).

In this embodiment, the two orthogonal image planes (active parallelframe 42 and active orthogonal frame 44) are always active andcontinually updated. Upon entry to the treatment mode (e.g., byactivating the footswitch), the device 10 stores captured referenceimages in memory. If the user chooses to view the reference images(e.g., in case the user pauses treatment and needs to reposition), theuser may select an icon to make the reference images visible. In atleast one embodiment, the screen format of the user interface 30 maychange to the aforementioned quad-view mode (see FIG. 14), with thecritical control functions 140 remaining consistently placed and visiblebetween the two formats. In an alternate embodiment, the screen formatof the user interface 30 may remain constant and reference parallelframe 46 and reference orthogonal frame 48 may be overlaid on the screenof the user interface 30 (see FIG. 15).

In another embodiment, the user may select more than two active imageplanes. For example, one may choose to view four image planes equallyspaced about the volume (e.g., 0, 45, 90, and 135 degrees) or about twoopposing quadrants (e.g., 0, 22.5, 67.5, and 90 degrees), etc. In yetanother embodiment, the display may include more than four image planes,for example with a relay out of the screen of the user interface 30and/or with a larger display.

In the aforementioned image display formats, the user may have theoption to also display the 360 degrees sweep view. In at least oneembodiment, this may be accomplished by replacing the biplane viewlayout with a single-view 360 degrees sweep layout. In anotherembodiment, the image display format may have a third view that isincluded with the two orthogonal views. This third view may have, in oneembodiment, the 360 degrees sweep view. In another embodiment, the thirdview could display a rendered 3D volume. In yet another embodiment, thethird view could display a coronal plane view. In another embodiment,four images could be displayed with two orthogonal active images, anactive 360 degrees sweep, and the coronal view. It is recognized andappreciated that one can display four or more live images simultaneouslywhere the displayed images are any combination of the aforementionedviews (e.g., two orthogonal views, 360 degrees swept view, coronal view,rendered 3D image, Doppler image, strain imaging image, and/or otherstandard imaging mode views).

As may be appreciated from the various implementations described herein,there are a variety of features and advantages obtained whenconstructing a device in accordance with the present disclosure.Furthermore, although the present disclosure has been described inconnection with certain depicted implementations, those of ordinaryskill will recognize that one or more features of a particularimplementation described herein may be used in another implementationfor similar advantage. Accordingly, it is not intended that the scope ofthe present disclosure in any way be limited by the precise formsdescribed above, but instead be determined by reference to the claimsthat follow and equivalents thereto.

The embodiments of the invention in which an exclusive property orprivilege is claimed are defined as follows:
 1. A high intensity focusedultrasound (HIFU) system for real-time, image-guided HIFU treatment oftissue, the system comprising: a HIFU applicator configured to deliverHIFU energy to the tissue; a HIFU generator configured to control andtransmit the HIFU energy to the HIFU applicator; an ultrasound imagingdevice configured to control imaging of the tissue; and a user interfaceincluding a display, wherein the user interface is configured to displayimages of the tissue on the display for three-dimensional visualizationof the tissue, wherein the images include an active parallel framedepicting a real-time image plane parallel to a feature of theapplicator and an active orthogonal frame depicting a real-time imageplane orthogonal to the active parallel plane.
 2. The system of claim 1,wherein the user interface is further configured to display referenceframes in addition to the active parallel frame and the activeorthogonal frame, wherein the reference frames include a referenceparallel frame and a reference orthogonal frame, and wherein thereference parallel frame provides a static view of the active parallelframe and the reference orthogonal frame provides a static view of theactive orthogonal frame.
 3. The system of claim 2, wherein the userinterface is further configured to display reference lines added to thereference parallel frame and the reference orthogonal frame, andduplicate the reference lines on the active parallel frame and theactive orthogonal frame.
 4. The system of claim 1, where the userinterface includes device controls for controlling the ultrasoundimaging device, wherein at least one of the device controls is a controlicon accessible via the display.
 5. The system of claim 4, wherein thesystem is configured to automatically set and adjust one or more of thedevice controls.
 6. The system of claim 1, wherein the system is furtherconfigured to: detect and mark tissue boundaries; calculate and adjusttreatment parameters based on the detected tissue boundaries; anddisplay the marked tissue boundaries on the display.
 7. The system ofclaim 6, wherein the system is configured to automatically detect andmark the tissue boundaries, and calculate and adjust the treatmentparameters based on the detected tissue boundaries.
 8. The system ofclaim 1, wherein the user interface is configured to display a 360degree sweep view of the tissue.
 9. The system of claim 1, wherein theultrasound imaging device is connected to the system via a dockinginterface.
 10. A method of interacting with a high intensity focusedultrasound (HIFU) system during real-time, image-guided HIFU treatmentof tissue, the method comprising: delivering HIFU energy to providetreatment to the tissue; and displaying ultrasound images of the tissueon a user interface during treatment, wherein the images include anactive parallel frame depicting a real-time image plane parallel to afeature of the applicator and an active orthogonal frame depicting areal-time image plane orthogonal to the active parallel plane.
 11. Themethod of claim 10, the method further comprising displaying referenceframes in addition to the active parallel frame and the activeorthogonal frame during treatment, wherein the reference frames includea reference parallel frame and a reference orthogonal frame, and whereinthe reference parallel frame provides a static view of the activeparallel frame and the reference orthogonal frame provides a static viewof the active orthogonal frame.
 12. The method of claim 11, the methodfurther comprising adding reference lines to the reference parallelframe and the reference orthogonal frame, and duplicating the referencelines on the active parallel frame and the active orthogonal frame. 13.The method of claim 10, the method further comprising controlling anultrasound imaging device through device controls, wherein at least oneof the device controls is a control icon accessible on a display. 14.The method of claim 13, the method further comprising automaticallysetting and adjusting one or more of the device controls.
 15. The methodof claim 10, the method further comprising detecting, marking, anddisplaying tissue boundaries, and calculating and adjusting treatmentparameters based on the detected tissue boundaries.
 16. The method ofclaim 15, the method further comprising automatically detecting,marking, and displaying tissue boundaries, and automatically calculatingand adjusting treatment parameters based on the detected tissueboundaries.
 17. The method of claim 10, the method further comprisingdisplaying a 360 degree sweep view of the tissue.